Physicians who don’t suggest a clinical trial until other efforts have failed are selling such studies and their potential volunteer patients short, says trial participant Linda Ridpath. Diagnosed with lupus 25 years ago, she is currently enrolled in her third study—this time for a drug already approved by the U.S. Food and Drug Administration (FDA) now being relabeled to treat the chronic autoimmune disease that can damage any part of the body (skin, joints, and/or organs).
“My doctor didn’t talk about it until we’d gone through [almost] everything else,” Ridpath said. “They make it sound like it’s a roll of the dice or a gamble.”
Instead, Ridpath says many patients will be receptive to the idea if it is presented earlier in their treatment regimen. “Maybe not as a last option, maybe as a middle option,” she said. “The outcomes for people on drug trials are probably better than the outcomes for patients who aren’t on drug trials.” It’s frustrating to see patients missing out on an opportunity to improve their care, she added.
While she has some mild criticism regarding vagaries in some of the intake forms in lupus clinical trials, overall, she’s very positive about her experience as a participant. That includes one trial for a drug that was ultimately shelved, she said. Ridpath was disappointed, of course, but understood that was a potential outcome of the trial.
The Lupus Foundation of America (LFA) is working to promote more clinical trial in lupus research. Despite more than an estimated 1.5 million cases in the United States, the condition lacks the research and drug development attention devoted to other conditions by the healthcare industry.
Last September, an LFA-led delegation met FDA officials to present recommendations for improving lupus clinical trial design and to discuss actionable steps toward advancing these solutions.
The recommendations are part of a white paper (Lupus Community Panel Proposals for Optimizing Clinical Trials: 2018), that was recently published in Lupus Science & Medicine. During the meeting, the delegation highlighted five key solutions for optimizing lupus clinical trials. These recommendations from the white paper would allow for smaller, more efficient trials; use of recent scientific breakthroughs to select patients; new approaches to involve the use of background medications; availability of trials to people with all types of lupus; and improvements in the tools by which the symptoms of people with lupus are measured.
“We’ve had only one new drug approved for lupus in the last 60 years,” Ridpath said. “We’re still pretty desperate for medicines that work. We need drug trials.”
Author: Michael Causey